search
Back to results

Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vitamin E ointment application
Vaseline ointment application
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain).
  • Haemorrhoids grade III and IV
  • The patients sign an Informed Consent Form agreeing their participation in the study.

Exclusion Criteria:

  • Patients undergoing other surgical techniques for haemorrhoidectomy, different tan Milligan Morgan
  • Haemorrhoids grade I and II
  • Patients with medical or surgical pathologies that do not allow the participation in the study
  • Disability to understand and accept the entry in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin E ointment

    Vaseline ointment

    Arm Description

    Vitamin E ointment application. Every 12 hours during 7 days.

    Vaseline ointment application. Every 12 hours during 7 days.

    Outcomes

    Primary Outcome Measures

    Postoperative pain
    Postoperative pain will be quantified with a VAS scale at the 1st, 3rd and 7th postoperative days

    Secondary Outcome Measures

    Need for morphine rescue
    Need for morphine rescue will be quantified in the first 24 hours after surgery during the hospital stay

    Full Information

    First Posted
    September 17, 2015
    Last Updated
    September 17, 2015
    Sponsor
    Hospital General Universitario Elche
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02554123
    Brief Title
    Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment
    Official Title
    Reduction of Postoperative Pain and Improvement of Patients´Comfort After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups: Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed. Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed. Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated.
    Detailed Description
    A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups: Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed. Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed. Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated by a blined epidemiology nurse.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin E ointment
    Arm Type
    Experimental
    Arm Description
    Vitamin E ointment application. Every 12 hours during 7 days.
    Arm Title
    Vaseline ointment
    Arm Type
    Placebo Comparator
    Arm Description
    Vaseline ointment application. Every 12 hours during 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin E ointment application
    Intervention Description
    Vitamin E ointment application. Every 12 hours during 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Vaseline ointment application
    Intervention Description
    Vaseline ointment application. Every 12 hours during 7 days.
    Primary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    Postoperative pain will be quantified with a VAS scale at the 1st, 3rd and 7th postoperative days
    Time Frame
    From the first to the 7th postoperative days
    Secondary Outcome Measure Information:
    Title
    Need for morphine rescue
    Description
    Need for morphine rescue will be quantified in the first 24 hours after surgery during the hospital stay
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain). Haemorrhoids grade III and IV The patients sign an Informed Consent Form agreeing their participation in the study. Exclusion Criteria: Patients undergoing other surgical techniques for haemorrhoidectomy, different tan Milligan Morgan Haemorrhoids grade I and II Patients with medical or surgical pathologies that do not allow the participation in the study Disability to understand and accept the entry in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manuel Duran, MD, PhD
    Organizational Affiliation
    Hospital Rey Juan Carlos
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment

    We'll reach out to this number within 24 hrs